Erchonia FX-405 Laser for Gum Disease

(R-GUM Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erchonia Corporation

Disqualifiers: Gingival recession, Oral cancer, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Erchonia® FX-405 laser treatment to determine its effectiveness in improving gum disease when combined with standard cleaning methods. The study compares this laser to a placebo laser to assess its actual effects. Individuals with gum disease who have lost four or fewer teeth due to the condition and have not undergone gum surgery in the past year may qualify for this trial. Participants must adhere to specific oral hygiene instructions and refrain from using smokeless tobacco or exceeding a certain daily nicotine intake. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for gum disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must not engage in any other treatments for periodontitis outside the study during your participation.

What prior data suggests that the Erchonia® FX-405 laser is safe for treating gum disease?

Research has shown that the Erchonia FX-405 laser has been safely used for conditions like chronic low back pain. The FDA has approved this laser for that specific use, indicating it is generally safe when used correctly.

The laser employs low-level light, often referred to as "cold laser" therapy. This treatment is noninvasive, meaning it doesn't involve cutting the skin. So far, no major safety issues have been reported with this laser in its approved use.

However, the laser should not be used near cancerous areas because its effects there remain unstudied. Although its existing approval supports confidence in its safety, this trial aims to determine its effectiveness for gum disease specifically. Researchers will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Erchonia® FX405 laser for gum disease because it offers a completely non-invasive treatment option using advanced laser technology. Unlike traditional treatments that often involve scaling, root planing, or surgery, the FX405 laser employs a novel mechanism, using red and violet laser diodes to potentially reduce inflammation and promote healing in gum tissue. This method of using light energy instead of traditional tools could mean less discomfort and faster recovery times for patients. Additionally, the robotic scanner device ensures precision in treatment delivery, which is a sophisticated advancement over standard care methods.

What evidence suggests that the Erchonia® FX-405 laser is effective for gum disease?

This trial will compare the Erchonia FX-405 laser with a placebo laser for treating gum disease. Research has shown that the Erchonia FX-405 laser may help treat gum disease, particularly periodontitis. This laser uses specific light wavelengths that might reduce swelling and aid in gum healing. Early studies suggest that using the laser alongside standard treatments like deep cleaning could improve gum health. Although more research is needed, initial results are promising for better managing periodontal disease. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with periodontitis, including those with diabetes-related gum issues. Participants should need treatment for their gum disease and be able to undergo procedures like scaling and root planing.

Inclusion Criteria

Subject has voluntarily signed a written informed consent form

I do not have aggressive gum disease.

Subject agrees to refrain from engaging in any other treatments for periodontitis outside the scope of this study during participation

Exclusion Criteria

Pregnant or intending to become pregnant in the next 8 months

Currently enrolled in a clinical study of an investigational drug or device

I have not had oral cancer or HIV in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active Erchonia FX-405 laser treatment or a placebo laser, in combination with periodontal scaling and root planing

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Erchonia® FX405

Trial Overview The study tests the Erchonia FX-405 laser's effectiveness as an additional treatment alongside standard care (scaling and root planing) in improving periodontal disease outcomes compared to a placebo laser.

How Is the Trial Designed?

Group I: Erchonia® FX405 Active Control 1 Intervention

The Erchonia® FX405 is made up of (3) 6405 nanometers red laser diodes and (1) 405 nanometers violet laser diode mounted in a robotic scanner device.

Group II: Placebo Laser Placebo Group 1 Intervention

The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.

Who Is Running the Clinical Trial?

Erchonia Corporation

Lead Sponsor

Trials

45

Recruited

2,100+

Published Research Related to This Trial

Using Er:YAG laser irradiation at lower energy levels (34 mJ/pulse) during root canal preparation showed no inflammation or damage to periodontal tissues in rats, indicating its safety when appropriate parameters are used.

In contrast, higher energy levels (102 mJ/pulse) resulted in significant inflammation and root surface resorption in 80% of cases, highlighting the importance of selecting the right laser settings to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on periradicular periodontal tissues of root canal irradiation with Er:YAG laser in rats. Kimura, Y., Yonaga, K., Murakoshi, M., et al.[2015]

The study involved 30 patients with grade II bifurcation lesions of chronic periodontitis, showing that treatment with Er: YAG laser combined with subgingival scaling significantly reduced pocket depth (PD) more than traditional scaling alone at both 12 and 20 weeks post-treatment.

Er: YAG laser treatment was found to be safe and effective, demonstrating significant improvements in periodontal clinical indexes, indicating its clinical value in managing chronic periodontitis with bifurcation lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of Er:YAG laser in the treatment of grade Ⅱ periodontitis with bifurcation lesions]. Wu, YZ., Zhou, Y., Mei, YM., et al.[2022]

The erbium family of lasers demonstrates effective calculus removal and has a proven antibacterial action, making it a valuable tool in periodontal therapy.

These lasers cause minimal removal of root substance while promoting cell attachment, suggesting they can enhance root surface bio-modification when used alongside conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Root Surface Bio-modification with Erbium Lasers- A Myth or a Reality?? Lavu, V., Sundaram, S., Sabarish, R., et al.[2022]

The Er:YAG laser effectively removed gingival melanin pigmentation in five patients, showing fast healing and healthy tissue appearance within one week after treatment.

After three months, complete healing was observed with no deformities or recession in most cases, indicating that this method is safe and provides significant aesthetic improvement, although there was a slight recurrence in one patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esthetic treatment of gingival melanin hyperpigmentation with Er:YAG laser: short-term clinical observations and patient follow-up. Rosa, DS., Aranha, AC., Eduardo, Cde P., et al.[2019]

The erbium: yttrium, aluminum, and garnet (Er:YAG) laser, when combined with a fluorescent calculus detection system, effectively removed subgingival calculus from periodontally diseased root surfaces, achieving results comparable to traditional scaling and root planing (SRP) without causing surface damage.

In contrast, the diode laser (DL) caused significant damage to the root surfaces, including crater formation, and was ineffective for calculus removal, highlighting its unsuitability for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo and in vitro effects of an Er:YAG laser, a GaAlAs diode laser, and scaling and root planing on periodontally diseased root surfaces: a comparative histologic study. Schwarz, F., Sculean, A., Berakdar, M., et al.[2022]

In a study involving 44 patients, both a resin-based desensitizer and an experimental glass-ionomer effectively reduced cervical dentin sensitivity over a 12-month period, but the glass-ionomer showed significantly better results at all follow-up points.

While the glass-ionomer treatment resulted in lower sensitivity scores, it also had some drawbacks, such as overhanging margins that could lead to plaque accumulation and gingivitis, yet it still maintained lower sensitivity levels compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a resin-modified glass-ionomer liner for cervical dentin hypersensitivity treatment. Tantbirojn, D., Poolthong, S., Leevailoj, C., et al.[2015]

In a clinical trial with 28 participants, treatment with diode laser significantly reduced dentin hypersensitivity (DH) to evaporative stimuli, showing a 25.4% reduction compared to only 17.1% for fluoride and 2.9% for placebo.

Fluoride treatment did not significantly affect DH levels, indicating that diode laser therapy is a more effective option for managing sensitivity related to gingival recession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of diode laser and fluoride on dentin hypersensitivity treatment: A randomized single-blinded clinical trial. Pantuzzo, ÉS., Cunha, FA., Abreu, LG., et al.[2022]

In a study involving 21 patients, both Er:YAG and diode lasers effectively treated gingival hyperpigmentation, but the diode laser resulted in less postoperative discomfort and pain.

The Er:YAG laser caused deeper tissue injury and delayed healing compared to the diode laser, suggesting that the diode laser may be a safer and more comfortable option for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial. Giannelli, M., Formigli, L., Bani, D.[2014]

The use of Er:YAG laser in simultaneous surgery for periapical granuloma and infraossal defects showed promising results, suggesting it may improve the survival rate of periodontally affected teeth with periapical lesions.

In this case report, the laser was effectively used for various surgical procedures, including flap dissection and granulation tissue removal, with successful outcomes observed over an 18-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Perio-endo Surgery with ER:YAG Laser and Bone Xenograft. A Case Report. Krastev, B., Filipov, I.[2021]

In a study involving 80 infected root canals in rats, Er:YAG laser irradiation at lower energy levels (34 mJ/pulse) showed no inflammation or damage to periodontal tissues, indicating its safety for use in root canal treatments.

Higher energy levels (68 and 102 mJ/pulse) resulted in mild to severe inflammation and root surface resorption, suggesting that careful selection of laser parameters is crucial for minimizing thermal damage during root canal preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological examination of experimentally infected root canals after preparation by Er:YAG laser irradiation. Kimura, Y., Tanabe, M., Imai, H., et al.[2021]

The Er:YAG laser treatment significantly altered the surface characteristics of dentin, creating a rough and irregular profile that affected cell adhesion and growth, particularly reducing the adhesion of human primary osteoblastic cells (hOBs).

While both periodontal ligament fibroblasts (PLFs) and hOBs proliferated on untreated dentin, PLFs showed better adhesion to the treated dentin, suggesting that the laser treatment may create a more favorable environment for PLF growth compared to hOBs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of laser-induced dentin modifications on periodontal fibroblasts and osteoblasts: a new in vitro model. Galli, C., Passeri, G., Cacchioli, A., et al.[2016]

The Erbium:YAG (Er:YAG) laser is a promising tool for periodontal treatment, showing effective results in soft and hard tissue ablation, including the removal of granulation tissue and gingival discoloration.

This laser not only minimizes damage during procedures but also promotes faster healing and has a bactericidal effect, making it beneficial for plaque and calculus removal and implant maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential applications of Erbium:YAG laser in periodontics. Ishikawa, I., Aoki, A., Takasaki, AA.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/an-evaluation-of-the-effect-of-the-erchonia-fx-405-laser-as-an-adjunctive-treatment-of-periodontitis

An Evaluation of the Effect of the Erchonia FX-405 Laser as an ... The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company)

2. trialx.com trialx.com/clinical-trials/listings/305585/an-evaluation-of-the-effect-of-the-erchonia-fx-405-laser-as-an-adjunctive-treatment-of-periodontitis/

An Evaluation of the Effect of the Erchonia FX-405 Laser ... The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) ...

3. app.trialscreen.org app.trialscreen.org/trials/evaluation-effect-erchonia-fx-405-laser-adjunctive-treatment-periodontitis-trial-nct06656325

An Evaluation of the Effect of the Erchonia FX-405 Laser as ... Benefits: Participants will receive careful monitoring and treatment for their gum disease, and may potentially benefit from the additional laser treatment if ...

4. clinconnect.io clinconnect.io/trials/NCT06656325

An Evaluation of the Effect of the Erchonia FX-405 Laser This clinical trial is studying the effectiveness of the Erchonia FX-405 laser as a supportive treatment for gum disease, specifically periodontitis, when ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/condition/593/Periodontitis?page=2

Periodontitis Clinical Research Trials ... Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis. The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 ...

6. erchonia.com erchonia.com/products/fx-405-product/

FX 405: Cold Laser for Chronic Pain Erchonia's FDA market cleared laser has been proven to effectively treat chronic low back pain. Contact Erchonia for more information.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231409.pdf

August 11, 2023 Erchonia Corporation Travis Sammons ... The Erchonia® FX-405 does not store any patient data. Cybersecurity is not considered a security or safety risk to users, nor does it pose a ...

8. erchonia.com erchonia.com/wp-content/uploads/2022/10/OM-MLS-AC-C-R2_FX-405-Credit.pdf

Operation & Maintenance Manual Read this entire booklet ... Laser treatment should not be applied over, or in proximity to, cancerous lesions as conclusive tests have not been conducted. The safety and effectiveness of ...